JP4588294B2 - Fixation device for fixing bones, especially vertebral bodies relative to each other - Google Patents

Fixation device for fixing bones, especially vertebral bodies relative to each other Download PDF

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JP4588294B2
JP4588294B2 JP2002547394A JP2002547394A JP4588294B2 JP 4588294 B2 JP4588294 B2 JP 4588294B2 JP 2002547394 A JP2002547394 A JP 2002547394A JP 2002547394 A JP2002547394 A JP 2002547394A JP 4588294 B2 JP4588294 B2 JP 4588294B2
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fixing device
locking element
blade
rear end
locking
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JP2004513757A (en
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フリドリン シュラプフェル
マルティン ヘッス
コンラート タークヴェルケル
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Synthes GmbH
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Stratec Medical AG
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7025Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a sliding joint
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00858Material properties high friction, non-slip

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Description

【0001】
(技術分野)
本発明は、骨、特に椎体を互いに相対的に固定するための請求項1の前文に係る装置に関する。
【0002】
(背景技術)
椎骨骨折、変質性変化等によって引き起こされることのある脊柱運動分節の不安定性はしばしば当該分節の癒合を必要とする。癒合すべき運動分節の骨癒合に必要な定着を達成するために、当該分節は固定システムでさまざまに安定させられる。これらの固定システムは後方から挿入して係止し、茎部内で骨ねじを用いて係止を行うか、あるいは、前方もしくは前外側から挿入して係止し、椎体内で骨ねじを用いて係止を行うかのいずれかである。
【0003】
固定システムの係止の質は骨構造の質に強く左右される。これは特に前外側で係止される固定システムの場合に妥当する。骨粗鬆病度が大きければ大きいほど、骨ねじがすでに小さな荷重において骨を切断する危険が一層大きくなる。太いねじを使用すると切断の危険が小さくなる。しかし他方で、椎体内の骨構造を過度に強く破壊しないために過度に太いねじは使用したくない。
【0004】
係止要素の切断の危険を減らすための解決策がDE29600879 AESCULAPとWO00/10473 AEBIに示してある。そこで問題となっているのは基本的に、椎体にねじ込まれる中空ねじである。この中空ねじは、骨を多く押しのけることなくそれが大きな外径を有する利点を有する。ねじ込むとき中空ねじの中心に錐状骨が残る。この解決策の欠点として、
a)中空ねじをねじ込むとき、中心に残る錐状骨の血管分布が大部分破壊され、これは特に骨粗鬆症の骨の場合問題を生じることがあり、
b)修理機構がまだ機能する骨の場合中空ねじは、点検時に除去困難になるほどに、もしくは除去時に大きな骨障害を生じるほどに、強固に定着することがある(例えば、頚椎に挿入された中空ねじは一部ではもはや除去できなかった)。
【0005】
管状骨の骨折の手術処置に関連して髄内安定化技術が開発されたが、前および前外側脊柱固定システムを係止する問題を解決するためにこの技術は転じて脊柱でも成功裏に利用できる。
【0006】
髄内釘は、骨折した管形骨の近位部を遠位部と髄内で結合することによって、骨折した管形骨の副子固定に利用される。しかし髄内釘はその幾何学のゆえに小さな回転荷重および軸方向荷重のみ吸収できる。これは、骨折した骨が軸方向荷重を受けて高さを保つことができかつ骨折が多かれ少なかれ骨幹にある限り、問題でない。しかし多破片的骨折が存在するや、髄内釘は近位側と遠位側で係止されねばならない。それとともに髄内釘はもはや副子固定に役立つだけでなく、脊柱の場合と同様に近位側および遠位側で係止された長手材として役立ち、この長手材はあらゆる平面において力およびモーメントを近位側から遠位側へと伝達できる。係止インプラントは、髄内釘の場合、遠位側および近位側で骨および髄内釘を横切って通されるねじである。骨粗鬆症や関節に近い骨折の場合、ねじによる髄内釘の係止はもはや十分でない。US3433220 ZICKEL、EP0411273 FRIGG、US4103683 NEUFELD、US4978349 FRIGG、DE4318150 FRIEDL、EP0491138 FRIGG、DE3730570 MATTHECK、WO98/30164 BRESINA、WO99/45858 HUNGERBUHLERに述べられかつ臨床的にも利用されているような螺旋状に捩られた刃状インプラントは脊柱で利用するには不適である。
【0007】
(発明の開示)
この点で本発明は救済策を提供せんとするものである。本発明の課題は、螺旋状に捩られた刃状係止要素を用いて椎体に固着可能かつ以下の付加的条件を考慮する脊柱固定装置を提供することである:
a)長手材を挿入する前に係止インプラントをセットし、これにより、複雑な照準装置と、長手材を基準にして係止要素を特別に整えることは不要になる;
b)長手材は係止インプラントの末端に嵌着される;
c)長手材と係止インプラントとの間の結合部が多軸で隙間なく角度安定的にロック可能かつ再び解除可能である;
d)係止要素は送り装置で引入れ可能でなければならず、これにより、未制御な打込みが不要になる。
【0008】
本発明のこの課題は、骨、特に椎体を互いに相対的に固定するための請求項1の特徴を有する固定装置で解決する。
【0009】
骨、特に椎体を互いに相対的に固定するための本発明による装置は実質的に、中心軸線を有する一つの縦方向長手材と、長手軸線と各一つの前端と各一つの後端とを有するn個の係止要素(2≦j≦n)とを含む。係止要素の長手軸線は長手材の中心軸線に対して好ましくは65°〜115°の角度に配置できる一方、係止要素は、後端に隣接して、前端に向かって刃形に構成されている。長手材と係止要素との間の結合部を解除可能にロックするための、後端の方から操作可能な保持手段を備えた長手材用受容手段を各係止要素が後端に含むことによって、係止要素の好ましくは角度変更可能な結合部は達成される。ロックされた結合部は長手材と係止要素との間の相対運動を可能とせずかつ三次元座標系の三つの軸方向全てにおいて力およびモーメントを吸収する。
【0010】
受容手段の実施形態に応じて係止要素の長手軸線と長手材の中心軸線との間の角度は固定されており、または軸線を中心に変更可能であり、または本発明による装置の他の実施形態において多軸で調整可能である。
【0011】
刃の表面はやはり、長さLと幅Bとによって限定された側で、または長さLと幅Bとによって限定された両方の側で、さまざまに構成しておくことができる:
a)平滑な表面;
b)鋸歯を有する;
c)鱗状;
d)矢形歯を有する;
e)粗い表面(例えばエッチング、プラズマ被覆、ブラスト);または
f)有孔(骨が孔内で成長することによる生物学的閉鎖)。
【0012】
表面構造は片面に、両面に、または刃表面の一部にのみ設けておくことができる。刃の各種構成はさまざまな表面と組合せ可能である。
【0013】
係止要素は打込みによってまたは送り装置を利用して椎体に挿入することができる。脊柱での未制御な打込みは一般に望ましくない(きわめて重要な神経・血管構造を損傷する危険)。考えられる送りシステム:
a)送りねじが刃(先端)に一体化されている;
b)相手皮質骨(Gegenkortikalis)内で係止される要素(ねじ、栓、フック等、延長部付き)は、刃を骨に引き入れるための受け部として役立つ;または
c)装置は係止要素を骨内に加圧するために皮質骨内で係止される。
【0014】
本発明の他の有利な諸構成は従属請求項に明示されている。
ねじを介して椎骨に係止される装置に比べて本発明は以下の利点を提供する:
1)骨内での切断に関する抵抗が高まり、同時に、押しのけられる骨質量が減少する:
単位長さ当りの支持面積が同じ:
−椎骨当り2本であってコア直径d=5mmの骨ねじを有するインプラント:
単位面積当りの支持面積:2×d×長さ/長さ= 10mm2/mm
単位長さ当りの押しのけ量:2×d2×Pi/4×長さ/長さ= 39mm2/mm
−椎骨当り幅B=10mm、中心の心部直径d=5mm、そして刃厚D=1.2mmの刃形係止要素を有するインプラント:
単位面積当りの支持面積:2×d×長さ/長さ= 10mm2/mm
単位長さ当りの押しのけ量:((B−d)×H+d2×Pi/4)×長さ/長さ= 25.6mm2/mm
すなわち、同じ支持面積において押しのけ量(ねじを除き)の34%減少が帰結する。
【0015】
単位長さ当り同じ押しのけ量(ねじを除く):
−椎骨当り2本であってコア直径d=5mmの骨ねじを有するインプラント:
単位長さ当りの押しのけ量:2×d2×Pi/4×長さ/長さ= 39mm2/mm
単位長さ当りの支持面積:2×d×長さ/長さ= 10mm2/mm
−椎骨当り幅B=?mm、中心の心部直径d=5mm、刃厚D=1.2mmの刃形係止要素を有するインプラント:
単位長さ当りの押しのけ量:((B−d)×H+d2×Pi/4)×長さ/長さ= 39mm2/mm
単位長さ当りの支持面積:((39mm2−d2×Pi/4)/H+d)×長さ/長さ= 21mm2/mm
すなわち、同じ押しのけ量において支持面積の110%増大が帰結する。
【0016】
2)ねじでもって椎体内で係止される装置は、癒合に不可欠な回転安定性を達成するために、椎骨当り少なくとも2本の骨ねじ、または留め金状基材と組合せて1本の骨ねじを必要とする。刃形係止要素はそれ自体回転安定的に骨内で係止されており、したがって、架橋する椎体の効果的癒合に不可欠な回転安定性を提供し、それとともに以下の利点を提供する:
−頭側と尾側で各1個の刃形係止要素を介して脊柱に結合された装置は、ねじを介して係止された嵩張るインプラントよりも高い位置で脊柱に挿入することができる;
−椎骨当り1個の係止要素に減らすことによって、刃形係止要素に基づくインプラントの組立は簡素になり促進される。
【0017】
(発明を実施するための最良の形態)
以下、幾つかの実施例の部分略図に基づいて本発明と本発明の諸構成がなお詳しく説明される。
【0018】
図1と図2に示す本発明による装置の実施形態は係止要素3を含み、この係止要素は係止要素3の後端6に長手材1用受容手段7を有する。受容手段7は係止要素3の長手軸線4に同軸な実質的に円筒形の受容頭部10からなり、この受容頭部は後端6に向かっ開口し、長手材1を受容するための通路11を有する。長手材1はその中心軸線2が長手軸線4に垂直に延びるように受容される。係止要素3は前端5と受容頭部10との間の領域に係止部分27を含み、この係止部分は実質的に直方体形の刃9として構成されている。刃9は長手軸線4に垂直に見て、幅Bであって、厚さDの長方形の横断面を有する。刃9の幅Bは係止要素3の前端5で収斂して尖端14となっている。さらに係止要素3の後端6で保持手段8として、長手軸線4と同軸な雄ねじ12が受容頭部10に設けられ、またこの雄ねじ12に螺着可能なナット13が配置されており、ナット13を締め付けると長手材1は通路11内で軸方向でしっかり締め付けられ、これにより係止要素3は長手材1に密着して動かなくされる。
【0019】
本発明による装置の図3に示す実施形態が含む係止要素3は長手軸線4と同軸な螺旋形刃9を係止部分27として有する。係止要素3の後端6で、長手軸線4と同軸で係止部分27に隣接して円錐部分23が配置され、またやはり同軸でこれに続いてねじ付き心棒25が配置されている。受容手段7は実質的に、穿孔された結合要素36からなり、そのなかで長手材1は中心軸線2(図2)と同軸で摺動可能に支承されかつ止めねじ35で保持可能である。長手材1の脇に延設して結合要素36内に、結合要素36を貫通する中空球形空洞38が配置されており、そのなかで球台形の溝付き緊締要素37が支承されている。緊締要素37が内側円錐部39を備えており、そのなかで係止要素3の円錐部分23が受容可能である。互いに直交する三つの軸線の周りを空洞38内で回転可能な緊締要素37を利用した係止要素3と結合要素36との間の結合によって、長手材1の中心軸線2と係止要素3の長手軸線4との間の角度は変更可能である。末端側ねじ付き心棒25に螺着可能なナット13でもって円錐部分23が緊締要素37の内側円錐部39に引き入れられ、これにより緊締要素37は半径方向で拡開されて空洞38内でしっかり締付けられ、係止要素3が結合要素36内で動かないようにされる。長手材1と係止要素3としての茎ねじとの間のこのような結合部がEP0599847 SCHLAEPFERに述べられている。円錐部分23およびねじ付き心棒25の代りに係止要素3の後端6に球形頭部を配置しておくことができ、この球形頭部は茎ねじとして構成された係止要素3に長手材1を結合するためのWO98/52482 SCHLAEPFERに開示されたような装置を利用して長手材1に結合可能である。
【0020】
係止要素3.jの後端6に長さLにわたって隣接した係止部分27の一実施形態が図4に示してある。係止部分27は実質的に、長さL、幅B、厚さDの平刃9からなる。刃9の側面32は長さLと厚さDとによって限定される。刃9の長手軸線4に垂直に見た横断面は、側面32の平面を延びかつ長手軸線4に垂直な第1横軸線29と、側面32に垂直かつ長手軸線4に垂直な第2横軸線30とを含む。厚さDに対する幅Bの比は実質的に1〜14、好ましくは3〜6である。この厚さDに対する幅Bの比のゆえに、インプラントは骨を大きく破壊することなく椎体に挿入することができる。その際、刃9は荷重の作用を考慮して骨内で整列させられる。第1横軸線29が脊柱の長手軸線と平行に延びるように刃9が椎体内に移植されると、刃9は曲げに対して高い強度を有するが、しかし骨切断の点で不都合な位置にある。それに対して第2横軸線30が脊柱の長手軸線と平行に延びるように刃9が椎体内に移植されると、骨切断の点で刃9の位置は好ましいものとなるが、しかしながらこれは刃9の曲げ強度低下と結び付いている。刃9は以下のように構成しておくことができる:
【0021】
a)長さL、厚さD、幅Bの直方体形状(図5a);
b)前端5に向かって幅Bが収斂する楔形(図5b);
c)前端5に向かって幅Bが拡がる楔形(図5c);
d)平面図で見て刃9は前端5が凸面状に構成されている(図5d);
e)平面図で見て刃9は前端5が等辺または不等辺で尖端14となっている(図5e);
f)平面図で見て刃9は前端5が片側で斜めにされている(図5f);
g)平面図で見て刃9は前端5が片側で丸くされている(図5g);
h)側面32と平行に延びる縦断面において刃9は前端5が等辺または不等辺で尖っている(図6a);
i)側面32と平行に延びる縦断面において刃9は前端5が片側で斜めにされている(図6b);
j)長手軸線4に垂直な横断面において刃9は側面32にある両方の側稜が尖端となる(図7a);
k)長手軸線4に垂直な横断面において刃9は側面32にある一つの側稜が尖端となる(図7b);
l)長手軸線4に垂直な横断面において刃9は側面32にある一つの側稜が斜めにされている(図7c);
m)長手軸線4に垂直な横断面において刃9は側面32にある両方の側稜が等しく斜めにされている(図7d);
n)長手軸線4に垂直な横断面において刃9は側面32にある両方の側稜が相逆向きに斜めにされている(図7e)。
【0022】
捩られた刃9の二つの実施形態が図8aと図8bに示してある。図8aが示す刃9は、側面32の一つに隣接して長さLを含む刃9の稜を中心に長さLにわたって捩り角αだけ捩られている。図8bが示す刃9は長手軸線4を中心に長さLにわたってやはり捩れ角αだけ捩られている。捩れは左捩りまたは右捩りとしておくことができる。捩れ長LV、捩れ角αの場合、捩りのピッチは以下のように定義することができる:
ピッチS=Lv *360°/α[°]
【0023】
刃9をこのように螺旋形に構成する場合、60mm〜300mm、好ましくは100mm〜240mmのピッチが有利である。
【0024】
図9aは刃9の組合せ体を有する係止要素3の他の実施形態を示す。この係止要素3は2枚の刃9を有する係止部分27を含み、係止要素3の全長にわたって長手軸線4と同軸に配置される中空体28によって刃は結合される。両方の刃9は、それらの第1横軸線29が一平面内にあるように配置されている。中空体28は長手軸線4と同軸で穴20が穿孔されている。
【0025】
係止要素3の図9bに示す実施形態は複数枚の刃9の他の組合せ体であり、この組合せ体は3枚の放射状に配置される刃9を含む。3枚の刃9の一つの側面32(図4)は長手軸線4と平行に同軸な中空円筒28に結合されており、刃9の第1横軸線29は長手軸線4を基準に中心角β、γ、δを成す。ここに示す実施形態において中心角β、γ、δは等しく、すなわちβ=γ=δであるが、他の実施形態において刃9は必要に応じてさまざまな中心角で配置しておくことができる。3枚以上の刃9を含む係止要素3は螺旋状に構成しておくこともできる。
【0026】
髄内釘システムの場合、刃形係止インプラントは打ち込まれる。脊柱の場合、打込みはきわめて重要な神経・血管構造を損傷する危険があるので厳禁である。
【0027】
送り装置15を利用して係止要素3を制御下に挿入する可能性が図10〜図13に示してある。図10に示す送り装置15が含む送りねじ16は、ねじ先端17と、ねじ軸部18と、ねじ先端17に隣接するねじ部分21と、駆動手段19とを有し、駆動手段19は係止要素3の後端6から操作可能である。送りねじ16は係止要素3に対して相対的に回転自在である。送りねじ16はねじ回し49で回されると骨内を螺旋状に動いて係止要素3を一緒に進める。
【0028】
ねじ部分21は図10と図11によれば係止部分27に一体化しておくことができ、ねじ山は刃9の厚さDから半径方向に張り出し、または係止要素3の前端5で係止部分27から末端側で突出する。さらに、ねじ部分21は長さLの一部にわたってのみまたは全長Lにわたって延設することができる。この送り装置15の利点は送りねじ16が係止部分27を直接に骨内に引き入れることにある。他方で欠点として椎体の中心で骨はごく多孔性であり、送りねじ16が空回りし、送り装置が機能しないことがある。
【0029】
図12において送り装置15が含む送りねじ16は中空体28の穴20内で支承され、係止要素3の前端5から突出し、相手皮質骨内で係止可能である。送りねじ16の場合のようにねじを利用して相手皮質骨内で係止する代りに、延長部を有する他の要素、例えば栓46(図16aと図16b)またはフック47(図17aと図17b)等も利用できる。係止要素3の後端6に送り装置15は送りねじ16に結合された延長部63を有し、この延長部は長さ部分Aにわたって同軸で係止要素3から突出し、末端側に受け部50を有する。こうして受け部50と係止要素3の後端6との間に拡開装置51を介装することができ、係止部分27は拡開装置51の拡開によって骨内に押し込むことができる。送り装置15のこの実施形態の利点は、最良と考えられる骨内で送りねじ16が最初から係止されていることにある。他方で、大きさの制限から費用のかかる器具が必要とされるのが欠点である。
【0030】
図13に象徴的に示したU形補助装置48は、係止部分27を係止要素3の後端6で拡開装置51によって骨内に加圧するために例えば骨ねじ52によって皮質骨内で受け部として係止される。ここでは補助装置48を係止するのに椎体の付加的穿孔が不可欠となることが不利に作用する。
【0031】
骨ねじや中空ねじと比較して、刃9は長手軸線4における係止強度が比較的乏しい欠点を有する。図10〜図12に示す送り装置15が係止強度を高める。
【0032】
図14a〜図14cは、刃9の表面造形によって長手軸線4における係止強度を高めることのできる可能性を示す:
a)刃9の長さLと幅Bとによって限定された表面の鋸歯状構成(図14a)。その際、鋸歯の急峻な側は係止要素3の前端5とは逆の方を向いている;または
b)刃9の長さLと幅Bとによって限定された表面の鱗状構成(図14b)。ここでも鱗の急峻な側は係止要素3の前端5とは逆の方を向いている。
【0033】
鋸歯状構成または鱗状構成は長さLと幅Bとによって限定された表面の一方にのみまたはこれらの表面の両方に設け、長さLの一部のみを占め、または全長Lにわたって延設することができる。
c)機械的閉鎖の代りに生物学的閉鎖も利用可能である。図14cに示すようにこの場合刃9は長さLと幅Bとによって限定された表面に垂直に複数の孔62が穿孔され、骨は孔62内を成長できる。
【0034】
図15の実施形態において、雄ねじ41を有するねじ込筒体40が係止要素3の後端6に配置されている。ねじ込筒体40が含む同軸な穴42は係止部分27と末端側円錐部分23との間に配置される円筒心棒43上にずらすことができる。送りねじ16(図10〜図12)と同様に、このねじ込筒体40はやはり骨内で係止要素3の係止強度を高めるのに役立つ。この実施形態は図10〜図14に示す変種と組合せて応用することができる。
【0035】
送り装置16(図12)を相手皮質骨内で係止するための装置が図16aと図16bに示してあり、この装置は送りねじ15(図12)の代りに利用可能である。これは、その第1末端56および第2末端57の方から同軸な溝55によって半径方向で弾力的に構成された中空円筒形栓46である(図16a)。図16aの実施形態において栓46の半径方向拡開は、やはり同軸なねじ棒54上に同軸で配置される二つの拡開円錐体53を利用して行われる。この拡開円錐体53はねじ棒54上の雄ねじと拡開円錐体53内の雌ねじとによって互いに移動可能である。図16bに示すように、拡開円錐体53の代りに楔要素58も栓46の半径方向拡開に利用できる。ここに示した栓46は第2末端57の方からのみ同軸で設けられた溝55を有し、栓46の拡開はねじ棒54を利用して楔要素58を同軸で引き入れることによって行われる。楔要素58は図16bに示すような4部分構成の代りに1部分構成、2部分構成または3部分構成とすることもできる。
【0036】
送り装置16(図12)を相手皮質骨内で係止するための他の装置が図17aと図17bに示してある。これは係止要素3(図1)の長手軸線4を基準に半径方向で拡開するフック47であり、その先端61に向かって先細となり、組立前および組立中、同軸に配置される筒体59によって半径方向で圧縮される。フック47は同軸な棒60を利用して導入される。フック47の導入後、筒体59は先端61とは反対側の末端を介してフック47から引き離され、これによりフック47は半径方向で弾力的に拡開して相手皮質骨内で係止される。
【0037】
図18は係止要素3を挿入した椎体63の横断面図であり、この係止要素は長手軸線4が脊柱の長軸を横切って椎体63に通されている。
【0038】
図19は本発明による装置を移植した複数の椎体63の側面図であり、この実施形態においてこの装置は中心軸線2を脊柱の長軸と平行にした一つの入れ子式長手材1と二つの係止要素3とを含む。
【図面の簡単な説明】
【図1】 本発明による装置の一実施形態の平面図である。
【図2】 本発明による装置の図1に示す実施形態の側面図である。
【図3】 本発明による装置の他の実施形態の側面図である。
【図4】 係止要素の一実施形態の斜視図である。
【図5】 a〜gは係止要素のさまざまな実施形態の平面図である。
【図6】 aとbは係止要素のさまざまな実施形態の側面図である。
【図7】 a〜eは係止要素のさまざまな実施形態の係止部分の横断面図である。
【図8】 aとbは係止要素のさまざまな実施形態における捩られた係止部分の斜視図である。
【図9】 aとbは係止要素のさまざまな実施形態における複数枚の刃からなる係止部分の斜視図である。
【図10】 送りねじを備えた螺旋形係止要素の一実施形態の斜視図である。
【図11】 3枚の刃を有する、送りねじを備えた係止要素の他の実施形態の斜視図である。
【図12】 送り装置を備えた係止要素の他の実施形態の斜視図である。
【図13】 送り装置で移植可能な係止要素の斜視図である。
【図14】 aは表面構造を有する係止要素の一実施形態の斜視図、bは表面構造を有する係止要素の別の実施形態の斜視図、cは横方向に延びる孔を有する係止要素の一実施形態の斜視図である。
【図15】 ねじ込筒体を備えた係止要素の一実施形態の斜視図である。
【図16】 aとbは係止要素を挿入するための送り装置を係止するための装置の斜視図である。
【図17】 aとbは係止要素を挿入するための送り装置を係止するための他の装置の斜視図である。
【図18】 係止要素を移植した椎体の横断面図である。
【図19】 本発明による装置を移植した脊柱の部分図である。
[0001]
(Technical field)
The invention relates to a device according to the preamble of claim 1 for fixing bones, in particular vertebral bodies relative to one another.
[0002]
(Background technology)
Instability of spinal motion segments, which can be caused by vertebral fractures, degenerative changes, etc., often requires fusion of the segments. In order to achieve the fixation necessary for bone union of the motor segments to be fused, the segments are variously stabilized with a fixation system. These fixation systems can be inserted and locked from the back and locked with bone screws in the stalk, or inserted and locked from the front or the front and outside, and bone screws can be used in the vertebral body To either stop.
[0003]
The locking quality of the fixation system is strongly dependent on the quality of the bone structure. This is especially true in the case of a fastening system that is locked on the front and outside. The greater the degree of osteoporosis, the greater the risk that the bone screw will cut the bone already under a small load. The use of thick screws reduces the risk of cutting. On the other hand, however, you do not want to use screws that are too thick to avoid destroying the bone structure in the vertebral body too strongly.
[0004]
Solutions for reducing the risk of breaking the locking element are shown in DE 29600879 AESCULAP and WO 00/10473 AEBI. The problem here is basically the hollow screw that is screwed into the vertebral body. This hollow screw has the advantage that it has a large outer diameter without pushing much bone away. When screwed, a conical bone remains in the center of the hollow screw. The disadvantage of this solution is that
a) When screwing a hollow screw, the vascular distribution of the conical bone that remains in the center is largely destroyed, which can cause problems, especially in osteoporotic bones,
b) For bones where the repair mechanism is still functioning The hollow screw may become so firmly fixed that it becomes difficult to remove at the time of inspection or a large bone damage is caused at the time of removal (for example, a hollow inserted into the cervical spine). Some of the screws could no longer be removed).
[0005]
Intramedullary stabilization technology has been developed in connection with surgical treatment of tubular bone fractures, but this technology has been successfully used in the spinal column to solve the problem of locking the anterior and anterolateral spinal fixation systems it can.
[0006]
Intramedullary nails are used for splinting a fractured tubular bone by joining the proximal portion of the fractured tubular bone with the distal portion in the medulla. However, intramedullary nails can only absorb small rotational and axial loads due to their geometry. This is not a problem as long as the fractured bone can be maintained in height under an axial load and the fracture is more or less in the shaft. However, in the presence of multi-fragment fractures, the intramedullary nail must be locked proximally and distally. At the same time, the intramedullary nail no longer serves for splint fixation, but as a longitudinal member locked proximally and distally as in the vertebral column, this longitudinal member exerts forces and moments in all planes. Can be transmitted from the proximal side to the distal side. Locking implants, in the case of intramedullary nails, are screws threaded across the bone and intramedullary nail distally and proximally. In the case of osteoporosis or fractures close to the joint, locking of the intramedullary nail with screws is no longer sufficient. US3433220 ZICKEL, EP0411273 FRIGG, US4103683 NEUFELD, US4978349 FRIGG, DE4318150 FRIEDL, EP0491138 FRIGG, DE37030570 MATTHECK, WO98 / 30164 BRESINA, WO99 / 45858 HUNGERBUHLER and the spiral as used clinically Blade implants are unsuitable for use in the spinal column.
[0007]
(Disclosure of the Invention)
In this respect, the present invention is intended to provide a remedy. It is an object of the present invention to provide a spinal fixation device that can be secured to a vertebral body using a helically twisted blade-like locking element and that considers the following additional conditions:
a) setting the locking implant before inserting the longitudinal member, which eliminates the need for complex aiming devices and special alignment of the locking element with respect to the longitudinal member;
b) the longitudinal member is fitted to the end of the locking implant;
c) The joint between the longitudinal member and the locking implant can be locked in a multi-axial and angle-free manner without gaps and can be released again;
d) The locking element must be retractable by the feeder, which eliminates the need for uncontrolled driving.
[0008]
This object of the invention is solved with a fixation device having the features of claim 1 for fixing bones, in particular vertebral bodies, relative to one another.
[0009]
The device according to the invention for fixing bones, in particular vertebral bodies relative to one another, essentially comprises a longitudinal longitudinal member having a central axis, a longitudinal axis, a respective front end and a respective rear end. And n locking elements (2 ≦ j ≦ n). The longitudinal axis of the locking element can be arranged at an angle of preferably 65 ° to 115 ° with respect to the central axis of the longitudinal member, while the locking element is arranged in a blade shape adjacent to the rear end and towards the front end. ing. Each locking element includes at its rear end receiving means for a longitudinal member with retaining means operable from the rear end for releasably locking the joint between the longitudinal member and the locking element By this, a preferably angle-changeable connection of the locking element is achieved. A locked joint does not allow relative movement between the longitudinal member and the locking element and absorbs forces and moments in all three axial directions of the three-dimensional coordinate system.
[0010]
Depending on the embodiment of the receiving means, the angle between the longitudinal axis of the locking element and the central axis of the longitudinal member is fixed or can be changed about the axis or other implementations of the device according to the invention The configuration can be adjusted with multiple axes.
[0011]
The blade surface can again be configured differently on the side defined by the length L and width B, or on both sides defined by the length L and width B:
a) smooth surface;
b) have saw blades;
c) scales;
d) having a sagittal tooth;
e) rough surface (eg etching, plasma coating, blasting); or f) perforation (biological closure by bone growing in the hole).
[0012]
The surface structure can be provided on one side, on both sides, or only on part of the blade surface. Various configurations of the blade can be combined with various surfaces.
[0013]
The locking element can be inserted into the vertebral body by driving or using a feeding device. Uncontrolled implantation in the spine is generally undesirable (risk of damaging vital nerve and vascular structures). Possible feeding systems:
a) the lead screw is integrated with the blade (tip);
b) The elements (screws, plugs, hooks, etc., with extensions) that are locked in the cortical bone (Gegenkortikalis) serve as receptacles for drawing the blades into the bone; or c) Locked in cortical bone to pressurize into the bone.
[0014]
Other advantageous configurations of the invention are specified in the dependent claims.
Compared to a device locked to a vertebra through a screw, the present invention provides the following advantages:
1) The resistance to cutting in the bone is increased, and at the same time the bone mass displaced is reduced:
Same support area per unit length:
-Implants with two bone screws per vertebra and a core diameter d = 5 mm:
Support area per unit area: 2 × d × length / length = 10 mm 2 / mm
Amount of displacement per unit length: 2 × d 2 × Pi / 4 × length / length = 39 mm 2 / mm
An implant with a blade-shaped locking element with a width per vertebra B = 10 mm, a central core diameter d = 5 mm and a blade thickness D = 1.2 mm:
Support area per unit area: 2 × d × length / length = 10 mm 2 / mm
Amount of displacement per unit length: ((B−d) × H + d 2 × Pi / 4) × length / length = 25.6 mm 2 / mm
That is, a 34% reduction in displacement (excluding screws) results in the same support area.
[0015]
Same displacement per unit length (excluding screw):
-Implants with two bone screws per vertebra and a core diameter d = 5 mm:
Amount of displacement per unit length: 2 × d 2 × Pi / 4 × length / length = 39 mm 2 / mm
Supporting area per unit length: 2 × d × length / length = 10 mm 2 / mm
-Width per vertebra B =? Implant having a blade-shaped locking element with mm, central core diameter d = 5 mm and blade thickness D = 1.2 mm:
Amount of displacement per unit length: ((B−d) × H + d 2 × Pi / 4) × length / length = 39 mm 2 / mm
Supporting area per unit length: ((39 mm 2 −d 2 × Pi / 4) / H + d) × length / length = 21 mm 2 / mm
That is, a 110% increase in the support area results at the same displacement.
[0016]
2) A device locked in the vertebral body with a screw is combined with at least two bone screws per vertebra or one clasp-like substrate to achieve the rotational stability essential for healing. Requires bone screws. The blade-shaped locking element itself is rotationally locked in the bone, thus providing the rotational stability essential for the effective fusion of the bridging vertebral bodies with the following advantages:
The device coupled to the spinal column via one blade-shaped locking element on each of the cranial and caudal sides can be inserted into the spinal column at a higher position than a bulky implant locked via a screw;
-By reducing to one locking element per vertebra, assembly of the implant based on the blade-shaped locking element is simplified and facilitated.
[0017]
(Best Mode for Carrying Out the Invention)
In the following, the present invention and the constructions of the invention will be explained in more detail on the basis of partial schematic diagrams of several embodiments.
[0018]
The embodiment of the device according to the invention shown in FIGS. 1 and 2 includes a locking element 3, which has a receiving means 7 for the longitudinal member 1 at the rear end 6 of the locking element 3. The receiving means 7 comprises a substantially cylindrical receiving head 10 coaxial with the longitudinal axis 4 of the locking element 3, which receiving head opens towards the rear end 6 for receiving the longitudinal member 1. A passage 11 is provided. The longitudinal member 1 is received such that its central axis 2 extends perpendicular to the longitudinal axis 4. The locking element 3 comprises a locking part 27 in the region between the front end 5 and the receiving head 10, this locking part being configured as a substantially rectangular parallelepiped blade 9. The blade 9 has a rectangular cross section with a width B and a thickness D as viewed perpendicular to the longitudinal axis 4. The width B of the blade 9 converges at the front end 5 of the locking element 3 to become a tip 14. Further, a male screw 12 coaxial with the longitudinal axis 4 is provided on the receiving head 10 as a holding means 8 at the rear end 6 of the locking element 3, and a nut 13 that can be screwed to the male screw 12 is disposed. When tightening 13, the longitudinal member 1 is firmly tightened in the axial direction in the passage 11, so that the locking element 3 is brought into close contact with the longitudinal member 1 and cannot be moved.
[0019]
The locking element 3 included in the embodiment shown in FIG. 3 of the device according to the invention has a helical blade 9 coaxial with the longitudinal axis 4 as the locking part 27. At the rear end 6 of the locking element 3, a conical portion 23 is arranged coaxially with the longitudinal axis 4 and adjacent to the locking portion 27, and also coaxially followed by a threaded mandrel 25. The receiving means 7 consists essentially of a perforated coupling element 36 in which the longitudinal member 1 is slidably supported coaxially with the central axis 2 (FIG. 2) and can be held by a set screw 35. A hollow spherical cavity 38 extending along the longitudinal member 1 and penetrating through the coupling element 36 is disposed in the coupling element 36, in which a spherical trapezoidal grooved tightening element 37 is supported. The tightening element 37 has an inner cone 39 in which the conical part 23 of the locking element 3 can be received. Due to the coupling between the locking element 3 and the coupling element 36 using a clamping element 37 which can rotate in a cavity 38 around three axes perpendicular to each other, the central axis 2 of the longitudinal member 1 and the locking element 3 The angle between the longitudinal axis 4 can be changed. The conical portion 23 is drawn into the inner conical portion 39 of the tightening element 37 with a nut 13 which can be screwed onto the distal threaded mandrel 25, so that the tightening element 37 is radially expanded and fastened in the cavity 38. The locking element 3 is prevented from moving in the coupling element 36. Such a connection between the longitudinal member 1 and a pedicle screw as a locking element 3 is described in EP 0599847 SCHLAEPFER. Instead of the conical part 23 and the threaded mandrel 25, a spherical head can be arranged at the rear end 6 of the locking element 3, which is connected to the locking element 3 configured as a pedicle screw in the longitudinal direction. It can be bonded to the longitudinal member 1 using an apparatus such as disclosed in WO 98/52482 SCHLAEPFER for bonding 1.
[0020]
2. locking element One embodiment of a locking portion 27 adjacent the rear end 6 of j over a length L is shown in FIG. The locking portion 27 substantially consists of a flat blade 9 having a length L, a width B, and a thickness D. The side surface 32 of the blade 9 is limited by the length L and the thickness D. The cross section of the blade 9 viewed perpendicularly to the longitudinal axis 4 is a first transverse axis 29 extending in the plane of the side surface 32 and perpendicular to the longitudinal axis 4 and a second transverse axis perpendicular to the side surface 32 and perpendicular to the longitudinal axis 4. 30. The ratio of width B to thickness D is substantially 1-14, preferably 3-6. Because of this ratio of width B to thickness D, the implant can be inserted into the vertebral body without significantly destroying the bone. At that time, the blade 9 is aligned in the bone in consideration of the effect of the load. When the blade 9 is implanted in the vertebral body so that the first transverse axis 29 extends parallel to the longitudinal axis of the spinal column, the blade 9 has a high strength against bending, but is inconvenient in terms of bone cutting. It is in. On the other hand, when the blade 9 is implanted into the vertebral body so that the second horizontal axis 30 extends parallel to the longitudinal axis of the spinal column, the position of the blade 9 is preferable in terms of bone cutting, however, This is associated with a decrease in the bending strength of the blade 9. The blade 9 can be configured as follows:
[0021]
a) a rectangular parallelepiped shape having a length L, a thickness D, and a width B (FIG. 5a);
b) a wedge shape with a width B converging towards the front end 5 (FIG. 5b);
c) a wedge shape with a width B increasing towards the front end 5 (FIG. 5c);
d) The blade 9 has a convex shape at the front end 5 as seen in plan view (FIG. 5d);
e) When viewed in plan view, the blade 9 is pointed 14 with the front end 5 being equilateral or unequal (FIG. 5e);
f) The blade 9 has a front end 5 that is slanted on one side as seen in plan view (FIG. 5f);
g) The blade 9 has a front end 5 which is rounded on one side as seen in plan view (FIG. 5g);
h) In a longitudinal section extending parallel to the side surface 32, the blade 9 is pointed at the front end 5 at equal or unequal sides (FIG. 6a);
i) In a longitudinal section extending parallel to the side surface 32, the blade 9 has the front end 5 inclined on one side (FIG. 6b);
j) In a cross section perpendicular to the longitudinal axis 4, the blade 9 is pointed at both side edges on the side 32 (FIG. 7a);
k) In a cross section perpendicular to the longitudinal axis 4, the blade 9 is pointed at one side ridge on the side 32 (FIG. 7b);
l) In a cross section perpendicular to the longitudinal axis 4, the blade 9 is beveled on one side ridge on the side 32 (FIG. 7c);
m) In a cross section perpendicular to the longitudinal axis 4, the blade 9 is equally beveled on both side edges on the side 32 (FIG. 7d);
n) In the cross-section perpendicular to the longitudinal axis 4, the blade 9 has both side ridges on the side 32 inclined in opposite directions (FIG. 7e).
[0022]
Two embodiments of the twisted blade 9 are shown in FIGS. 8a and 8b. The blade 9 shown in FIG. 8 a is twisted by a twist angle α over the length L around the ridge of the blade 9 including the length L adjacent to one of the side surfaces 32. The blade 9 shown in FIG. 8b is also twisted by a twist angle α over a length L about the longitudinal axis 4. The twist can be left-handed or right-handed. For a torsion length L V and a torsion angle α, the torsion pitch can be defined as follows:
Pitch S = Lv * 360 ° / α [°]
[0023]
When the blade 9 is configured in this way, a pitch of 60 mm to 300 mm, preferably 100 mm to 240 mm, is advantageous.
[0024]
FIG. 9 a shows another embodiment of the locking element 3 with a combination of blades 9. This locking element 3 comprises a locking part 27 having two blades 9, the blades being joined by a hollow body 28 arranged coaxially with the longitudinal axis 4 over the entire length of the locking element 3. Both blades 9 are arranged such that their first transverse axis 29 is in one plane. The hollow body 28 is coaxial with the longitudinal axis 4 and has a hole 20 drilled therein.
[0025]
The embodiment shown in FIG. 9 b of the locking element 3 is another combination of a plurality of blades 9, which combination includes three blades 9 arranged radially. One side 32 (FIG. 4) of the three blades 9 is coupled to a hollow cylinder 28 that is coaxial with the longitudinal axis 4 in parallel, and the first horizontal axis 29 of the blade 9 has a central angle β with respect to the longitudinal axis 4. , Γ, and δ. In the embodiment shown here, the central angles β, γ, δ are equal, ie β = γ = δ, but in other embodiments the blade 9 can be arranged at various central angles as required. . The locking element 3 including three or more blades 9 can be formed in a spiral shape.
[0026]
In the case of an intramedullary nail system, the blade locking implant is driven. In the case of the vertebral column, driving is strictly prohibited as it can damage vital nerve and vascular structures.
[0027]
The possibility of inserting the locking element 3 under control using the feeding device 15 is shown in FIGS. The feed screw 16 included in the feed device 15 shown in FIG. 10 includes a screw tip 17, a screw shaft portion 18, a screw portion 21 adjacent to the screw tip 17, and a drive means 19. The drive means 19 is locked. It can be operated from the rear end 6 of the element 3. The feed screw 16 is rotatable relative to the locking element 3. When the feed screw 16 is turned by a screwdriver 49, it moves in a spiral manner in the bone and advances the locking element 3 together.
[0028]
The screw part 21 can be integrated in the locking part 27 according to FIGS. 10 and 11, and the thread extends radially from the thickness D of the blade 9 or is engaged at the front end 5 of the locking element 3. Projects from the stop portion 27 on the distal side. Furthermore, the threaded portion 21 can extend only over a part of the length L or over the entire length L. The advantage of this feed device 15 is that the feed screw 16 pulls the locking portion 27 directly into the bone. On the other hand, the disadvantage is that the bone is very porous at the center of the vertebral body and the feed screw 16 runs idle and the feed device does not work.
[0029]
In FIG. 12, the feed screw 16 included in the feed device 15 is supported in the hole 20 of the hollow body 28, protrudes from the front end 5 of the locking element 3, and can be locked in the cortical bone. Instead of locking in the mating cortical bone using a screw as in the case of the lead screw 16, other elements having extensions, such as plugs 46 (FIGS. 16a and 16b) or hooks 47 (FIGS. 17a and 17b). 17b) can also be used. At the rear end 6 of the locking element 3, the feeding device 15 has an extension 63 connected to the feed screw 16, which extends coaxially over the length A and protrudes from the locking element 3, with a receiving part on the distal side. 50. Thus, the spreading device 51 can be interposed between the receiving portion 50 and the rear end 6 of the locking element 3, and the locking portion 27 can be pushed into the bone by the spreading of the spreading device 51. The advantage of this embodiment of the feed device 15 is that the feed screw 16 is locked from the beginning in the bone considered to be the best. On the other hand, the disadvantage is that expensive equipment is required due to size limitations.
[0030]
The U-shaped auxiliary device 48 shown symbolically in FIG. 13 is used in the cortical bone, for example by means of bone screws 52, in order to press the locking part 27 into the bone by the spreading device 51 at the rear end 6 of the locking element 3. Locked as a receiving part. Here, it is disadvantageous that an additional perforation of the vertebral body is essential for locking the auxiliary device 48.
[0031]
Compared with bone screws and hollow screws, the blade 9 has the disadvantage that the locking strength in the longitudinal axis 4 is relatively poor. 10 to 12 increases the locking strength.
[0032]
Figures 14a to 14c show the possibility that the locking strength at the longitudinal axis 4 can be increased by surface shaping of the blade 9:
a) A serrated configuration of the surface defined by the length L and width B of the blade 9 (FIG. 14a). In so doing, the sharp side of the saw blade faces away from the front end 5 of the locking element 3; or b) a scale-like configuration of the surface limited by the length L and width B of the blade 9 (FIG. 14b). ). Again, the steep side of the scale is facing away from the front end 5 of the locking element 3.
[0033]
The serrated or scale-like configuration is provided on only one or both of the surfaces defined by the length L and the width B, occupies only a part of the length L, or extends over the entire length L Can do.
c) Biological closure can also be used instead of mechanical closure. In this case, as shown in FIG. 14 c, the blade 9 is perforated with a plurality of holes 62 perpendicular to the surface defined by the length L and the width B, so that bone can grow in the holes 62.
[0034]
In the embodiment of FIG. 15, a threaded cylinder 40 having a male thread 41 is arranged at the rear end 6 of the locking element 3. The coaxial hole 42 included in the screw-in cylinder 40 can be shifted on a cylindrical mandrel 43 disposed between the locking portion 27 and the distal cone portion 23. Similar to the feed screw 16 (FIGS. 10 to 12), this threaded barrel 40 also serves to increase the locking strength of the locking element 3 in the bone. This embodiment can be applied in combination with the variants shown in FIGS.
[0035]
A device for locking the feed device 16 (FIG. 12) in the counterpart cortical bone is shown in FIGS. 16a and 16b, which can be used in place of the feed screw 15 (FIG. 12). This is a hollow cylindrical plug 46 that is resiliently configured in a radial direction by a groove 55 coaxial from its first end 56 and second end 57 (FIG. 16a). In the embodiment of FIG. 16 a, the radial expansion of the plug 46 takes place using two expanding cones 53 that are coaxially arranged on a coaxial screw rod 54. The expanding cone 53 is movable relative to each other by a male screw on the screw rod 54 and a female screw in the expanding cone 53. As shown in FIG. 16 b, instead of the expanding cone 53, a wedge element 58 can also be used for the radial expansion of the plug 46. The plug 46 shown here has a groove 55 provided coaxially only from the second end 57, and the expansion of the plug 46 is effected by drawing the wedge element 58 coaxially using the screw rod 54. . The wedge element 58 can be a one-part, two-part or three-part configuration instead of a four-part configuration as shown in FIG. 16b.
[0036]
Another device for locking the feeder 16 (FIG. 12) within the counterpart cortical bone is shown in FIGS. 17a and 17b. This is a hook 47 that expands in the radial direction with respect to the longitudinal axis 4 of the locking element 3 (FIG. 1), and tapers toward the tip 61 of the hook 47, which is arranged coaxially before and during assembly. 59 is compressed radially. The hook 47 is introduced using a coaxial bar 60. After the hook 47 is introduced, the cylindrical body 59 is pulled away from the hook 47 via the end opposite to the tip 61, and thereby the hook 47 is elastically expanded in the radial direction and locked in the cortical bone. The
[0037]
FIG. 18 is a cross-sectional view of the vertebral body 63 with the locking element 3 inserted therein, with the longitudinal axis 4 being passed through the vertebral body 63 across the longitudinal axis of the spinal column.
[0038]
FIG. 19 is a side view of a plurality of vertebral bodies 63 implanted with a device according to the present invention, in this embodiment the device comprises a telescopic longitudinal member 1 with two central axes 2 parallel to the long axis of the spine and two A locking element 3.
[Brief description of the drawings]
FIG. 1 is a plan view of an embodiment of an apparatus according to the present invention.
FIG. 2 is a side view of the embodiment shown in FIG. 1 of an apparatus according to the present invention.
FIG. 3 is a side view of another embodiment of the device according to the invention.
FIG. 4 is a perspective view of one embodiment of a locking element.
FIGS. 5a-g are plan views of various embodiments of locking elements. FIG.
FIGS. 6a and 6b are side views of various embodiments of locking elements. FIGS.
FIGS. 7a-e are cross-sectional views of locking portions of various embodiments of locking elements. FIGS.
FIGS. 8a and 8b are perspective views of twisted locking portions in various embodiments of locking elements. FIGS.
FIGS. 9a and 9b are perspective views of a locking portion comprising a plurality of blades in various embodiments of locking elements. FIGS.
FIG. 10 is a perspective view of one embodiment of a helical locking element with a lead screw.
11 is a perspective view of another embodiment of a locking element with a lead screw having three blades. FIG.
FIG. 12 is a perspective view of another embodiment of a locking element with a feeding device.
13 is a perspective view of a locking element implantable with a feeder device. FIG.
14 is a perspective view of an embodiment of a locking element having a surface structure, b is a perspective view of another embodiment of a locking element having a surface structure, and c is a locking with a laterally extending hole. FIG. FIG. 6 is a perspective view of one embodiment of an element.
FIG. 15 is a perspective view of one embodiment of a locking element with a threaded barrel.
16 a and b are perspective views of a device for locking a feed device for inserting a locking element. FIG.
FIGS. 17a and b are perspective views of another device for locking a feeding device for inserting a locking element. FIGS.
FIG. 18 is a cross-sectional view of a vertebral body implanted with a locking element.
FIG. 19 is a partial view of a spinal column implanted with a device according to the present invention.

Claims (51)

骨を互いに相対的に固定するための固定装置であって、
A)中心軸線(2)を有する一つの縦方向長手材(1)と、
B)長手軸線(4)と各一つの前端(5)と各一つの後端(6)とを有するn個の係止要素(3.i)(2≦i≦n)とを含み、
C)係止要素(3.i)の長手軸線(4)が長手材(1)の中心軸線(2)に対して65°〜115°の角度にあり、
D)係止要素(3.j)(1≦j≦n)の少なくとも一つが刃形に構成されているものにおいて、
E)少なくともこの係止要素(3.j)が、長手材(1)と係止要素(3.j)との間の結合部を解除可能にロックするための保持手段(8;34)を有する長手材(1)用受容手段(7)を後端(6)に含み、
F)結合部がロックされた状態で、長手材(1)と係止要素(3.j)との間の相対運動を可能とせずかつ前記結合部は力およびモーメントを吸収し、
G)少なくとも一つの係止要素(3.j)が、係止要素(3.j)を長手軸線(4)と平行に骨に挿入するための送り装置(15)を含み、
H)前記送り装置は、前記係止要素(3.j)の後端(6)の方から操作可能な駆動手段(19)を備え、さらに、
i)送りねじ、または
ii)延長部付きのねじ、栓もしくはフックであって該延長部の末端側に受け部(50)を有するねじ、栓もしくはフックを備え、
I)係止要素(3.j)は連続した穴(20)を、該穴(20)の長手軸線(4)と同軸で有し、前記送り装置は前記穴(20)内に受容可能であることを特徴とする固定装置。
A fixation device for fixing bones relative to each other,
A) one longitudinal longitudinal member (1) having a central axis (2);
B) n locking elements (3.i) (2 ≦ i ≦ n) having a longitudinal axis (4), each one front end (5) and each one rear end (6),
C) the longitudinal axis (4) of the locking element (3.1) is at an angle of 65 ° to 115 ° with respect to the central axis (2) of the longitudinal member (1);
D) In the case where at least one of the locking elements (3.j) (1 ≦ j ≦ n) is formed in a blade shape,
E) At least this locking element (3.j) has retaining means (8; 34) for releasably locking the joint between the longitudinal member (1) and the locking element (3.j) Comprising a receiving means (7) for the longitudinal member (1) at the rear end (6),
F) With the coupling part locked, it does not allow relative movement between the longitudinal member (1) and the locking element (3.j) and the coupling part absorbs forces and moments;
G) at least one locking element (3.j) comprises a feeding device (15) for inserting the locking element (3.j) into the bone parallel to the longitudinal axis (4);
H) The feeding device comprises drive means (19) operable from the rear end (6) of the locking element (3.j) ,
i) a lead screw, or ii) a screw, plug or hook with an extension , having a receptacle (50) on the distal side of the extension,
I) The locking element (3.j) has a continuous hole (20) coaxial with the longitudinal axis (4) of the hole (20), the feeding device being receivable in the hole (20). A fixing device characterized by being.
少なくとも一つの係止要素(3.j)(1≦j≦n)が係止要素(3.j)の後端(6)に隣接して刃形に構成されていることを特徴とする、請求項1記載の固定装置。  At least one locking element (3.j) (1 ≦ j ≦ n) is configured in the form of a blade adjacent to the rear end (6) of the locking element (3.j), The fixing device according to claim 1. 保持手段(8)が少なくとも一つの係止要素(3.j)の後端(6)の方から操作可能であることを特徴とする、請求項1または2記載の固定装置。3. Fixing device according to claim 1 or 2, characterized in that the holding means (8) are operable from the rear end (6) of at least one locking element (3.j). 受容部(7)が横方向で開口しており、長手材(1)が長手軸線(4)を横切って受容部(7)に導入可能であることを特徴とする、請求項1〜3のいずれか1項記載の固定装置。  The receiving part (7) is open laterally and the longitudinal member (1) can be introduced into the receiving part (7) across the longitudinal axis (4). The fixing device according to claim 1. 前記受容部(7)は、前記後端(6)に向かって開口して前記長手材(1)を受容する通路(11)であって前記長手材(1)の中央軸線(2)が前記係止要素(3)の前記長手軸線(4)に対して垂直に延びる通路(11)を有することを特徴とする、請求項1〜3のいずれか1項記載の固定装置。 The receiving portion (7) is a passage (11) that opens toward the rear end (6) and receives the longitudinal member (1) , and the central axis (2) of the longitudinal member (1 ) is 4. Fixing device according to any one of the preceding claims, characterized in that it comprises a passage (11) extending perpendicular to the longitudinal axis (4 ) of the locking element (3) . 送り装置(15)が送りねじ(16)として実施されていることを特徴とする、請求項1〜5のいずれか1項記載の固定装置。  6. Fixing device according to any one of the preceding claims, characterized in that the feed device (15) is implemented as a feed screw (16). 送りねじ(16)がねじ先端(17)と、ねじ軸部(18)と、ねじ先端(17)に隣接するねじ部分(21)と、駆動手段(19)とを含むことを特徴とする、請求項6記載の固定装置。  The feed screw (16) includes a screw tip (17), a screw shaft portion (18), a screw portion (21) adjacent to the screw tip (17), and drive means (19). The fixing device according to claim 6. 駆動手段(19)が係止要素(3.j)の後端(6)の方から操作可能であることを特徴とする、請求項7記載の固定装置。8. Fixing device according to claim 7, characterized in that the drive means (19) are operable from the rear end (6) of the locking element (3.j). 少なくとも一つの係止要素(3.j)が連続した穴(20)を同軸で有し、送りねじ(16)がこの穴(20)内で受容可能であり、ねじ先端(17)とねじ部分(21)が係止要素(3.j)の前端(5)から軸方向で突出することを特徴とする、請求項8記載の固定装置。  At least one locking element (3.j) has a continuous hole (20) coaxially, a lead screw (16) is receivable in this hole (20), a screw tip (17) and a threaded part 9. Fixing device according to claim 8, characterized in that (21) projects axially from the front end (5) of the locking element (3.j). 少なくとも一つの係止要素(3.j)が連続した穴(20)を同軸で有し、送りねじ(16)がこの穴(20)内で受容可能であり、ねじ部分(21)が係止要素(3.j)に一体化されており、かつその周面の一部にわたって長手軸線(4)に垂直に係止要素(3.j)から半径方向に突出することを特徴とする、請求項8記載の固定装置。  At least one locking element (3.j) has a continuous hole (20) coaxially, a lead screw (16) is receivable within this hole (20) and a threaded portion (21) is locked Integrated into the element (3.j) and projecting radially from the locking element (3.j) perpendicular to the longitudinal axis (4) over a part of its peripheral surface, Item 9. The fixing device according to Item 8. 少なくとも一つの係止要素(3.j)の後端(6)が同軸な円錐部分(23)を有することを特徴とする、請求項1〜10のいずれか1項記載の固定装置。  11. Fixing device according to any one of the preceding claims, characterized in that the rear end (6) of the at least one locking element (3.j) has a coaxial conical part (23). 円錐部分(23)が、軸方向末端側で開口した同軸なねじ穴(24)を有することを特徴とする、請求項11記載の固定装置。  12. Fixing device according to claim 11, characterized in that the conical part (23) has a coaxial threaded hole (24) which is open at the axial end. 雄ねじを有する同軸な心棒(25)が軸方向末端側で円錐部分(23)に続くことを特徴とする、請求項11記載の固定装置。  12. Fixing device according to claim 11, characterized in that a coaxial mandrel (25) with external threads follows the conical part (23) on the axial end side. 受容手段(7)が、係止要素(3.j)の後端(6)に隣接する同軸な球形頭部を含むことを特徴とする、請求項1〜10のいずれか1項記載の固定装置。  11. Fixing according to any one of the preceding claims, characterized in that the receiving means (7) comprises a coaxial spherical head adjacent the rear end (6) of the locking element (3.j). apparatus. 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、厚さ(D)、幅(B)の長方形の横断面を有する少なくとも1枚の刃(9)を有し、この刃(9)は横断面の長辺と平行な第1横軸線(29)を含むことを特徴とする、請求項1〜14のいずれか1項記載の固定装置。  The locking part (27) which the locking element (3.j) includes over the length (L) adjacent to the rear end (6) has a rectangular cross section of thickness (D), width (B) 15. The method as claimed in claim 1, wherein the blade (9) includes at least one blade (9), the blade (9) including a first horizontal axis (29) parallel to the long side of the cross section. The fixing device according to the item. 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、平面図で見て前端(5)に向かって収斂する少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜14のいずれか1項記載の固定装置。  At least one locking part (27) that the locking element (3.j) includes over the length (L) adjacent to the rear end (6) converges towards the front end (5) in plan view The fixing device according to claim 1, wherein the fixing device has a blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、平面図で見て前端(5)に向かって拡がる少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜14のいずれか1項記載の固定装置。  The locking part (27), which the locking element (3.j) includes over the length (L) adjacent to the rear end (6), is at least one piece extending towards the front end (5) in plan view. 15. Fixing device according to any one of the preceding claims, characterized in that it has a blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、平面図で見て前端(5)が尖端(14)へと収斂する少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜14のいずれか1項記載の固定装置。  The locking part (27) that the locking element (3.j) includes over the length (L) adjacent to the rear end (6) converges the front end (5) to the pointed end (14) when viewed in plan view. 15. Fixing device according to any one of the preceding claims, characterized in that it has at least one blade (9) that does. 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、平面図で見て前端(5)が片側で斜めにされた少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜14のいずれか1項記載の固定装置。  The locking part (27) which the locking element (3.j) includes over the length (L) adjacent to the rear end (6) has at least the front end (5) beveled on one side when viewed in plan view 15. Fixing device according to any one of the preceding claims, characterized in that it has one blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、平面図で見て前端(5)が凸面状の少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜14のいずれか1項記載の固定装置。  The locking portion (27) that the locking element (3.j) includes over the length (L) adjacent to the rear end (6) is at least one sheet of which the front end (5) is convex in plan view. 15. Fixing device according to any one of the preceding claims, characterized in that it has a blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、縦断面図で見て前端(5)が尖端へと収斂する少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜20のいずれか1項記載の固定装置。  The locking portion (27) that the locking element (3.j) includes over the length (L) adjacent to the rear end (6) has at least a front end (5) that converges to a point when viewed in longitudinal section. 21. Fixing device according to any one of the preceding claims, characterized in that it has one blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、縦断面図で見て前端(5)が片側で斜めにされた少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜20のいずれか1項記載の固定装置。Catch including over locking element (3.J) in length adjacent to the rear end (6) (L) (27) is the front viewed in longitudinal section (5) is obliquely on one side 21. Fixing device according to any one of the preceding claims, characterized in that it has at least one blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、横断面図で見て少なくとも一つの側面(32)を尖らせた少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜22のいずれか1項記載の固定装置。  The locking part (27) that the locking element (3.j) includes over its length (L) adjacent to the rear end (6) has a sharpened at least one side (32) as viewed in cross section 23. Fixing device according to any one of the preceding claims, characterized in that it has at least one blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、横断面図で見て少なくとも一つの側面(32)が片側で斜めにされた少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜22のいずれか1項記載の固定装置。  The locking part (27), which the locking element (3.j) includes over the length (L) adjacent to the rear end (6), is at least one side (32) oblique on one side when viewed in cross section 23. Fixing device according to any one of the preceding claims, characterized in that it has at least one blade (9) that is made. 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、一つの側面(32)に隣接する稜を中心に長さ(L)にわたって捩られた少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜24のいずれか1項記載の固定装置。  The locking portion (27) that the locking element (3.j) includes over the length (L) adjacent to the rear end (6) has a length (L) about the ridge adjacent to one side surface (32). 25. Fixing device according to any one of the preceding claims, characterized in that it has at least one blade (9) twisted over. 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって含む係止部分(27)は、長さ(L)にわたって長手軸線(4)を中心に捩られた少なくとも1枚の刃(9)を有することを特徴とする、請求項1〜24のいずれか1項記載の固定装置。  The locking portion (27) that the locking element (3.j) includes over the length (L) adjacent to the rear end (6) was twisted about the longitudinal axis (4) over the length (L) 25. Fixing device according to any one of the preceding claims, characterized in that it has at least one blade (9). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって、2枚の刃(9)を備えた係止部分(27)を含むことを特徴とする、請求項1〜26のいずれか1項記載の固定装置。  The locking element (3.j) comprises a locking part (27) with two blades (9) over a length (L) adjacent to the rear end (6) Item 27. The fixing device according to any one of Items 1 to 26. 前記2枚の刃(9)が横断面で見て1平面にあることを特徴とする、請求項27記載の固定装置。28. Fixing device according to claim 27, characterized in that the two blades (9) are in one plane when viewed in cross section. 前記2枚の刃(9)が長手軸線(4)と平行な棒によって分離されていることを特徴とする、請求項27または28記載の固定装置。 29. Fixing device according to claim 27 or 28, characterized in that the two blades (9) are separated by a bar parallel to the longitudinal axis (4). 棒が、長手軸線(4)と平行に穿孔された中空体28であることを特徴とする、請求項29記載の固定装置。  30. Fixing device according to claim 29, characterized in that the rod is a hollow body (28) drilled parallel to the longitudinal axis (4). 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって、3枚以上の刃(9)を備えた係止部分(27)を含み、係止部分(27)が放射状横断面を有することを特徴とする、請求項1〜26のいずれか1項記載の固定装置。  The locking element (3.j) includes a locking part (27) with three or more blades (9) over a length (L) adjacent to the rear end (6), 27) Fixing device according to any one of claims 1 to 26, characterized in that it has a radial cross section. 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって、3枚以上の刃(9)を備えた係止部分(27)を含み、刃(9)が係止部分(27)の横断面で見て中心角を非同一にして配置されていることを特徴とする、請求項1〜26のいずれか1項記載の固定装置。  The locking element (3.j) includes a locking portion (27) with three or more blades (9) over a length (L) adjacent to the rear end (6), the blade (9) 27. Fixing device according to any one of the preceding claims, characterized in that it is arranged with non-identical central angles as seen in the cross section of the locking part (27). 係止要素(3.j)が、係止要素(3.j)を前端(5)から後端(6)に至るまで貫通したやはり同軸な穴(20)を備えた同軸な中空体(28)を含むことを特徴とする、請求項1〜32のいずれか1項記載の固定装置。  The coaxial hollow body (28) with the locking element (3.j) also having a coaxial hole (20) that passes through the locking element (3.j) from the front end (5) to the rear end (6). The fixing device according to any one of claims 1 to 32, comprising: 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって、少なくとも1枚の刃(9)を備えた係止部分(27)を含み、少なくとも1枚の刃(9)が鋸歯状表面構造を有し、鋸歯の急峻な側が係止要素(3.j)の後端(6)の方を向いていることを特徴とする、請求項1〜33のいずれか1項記載の固定装置。  The locking element (3.j) includes a locking portion (27) with at least one blade (9) over a length (L) adjacent to the rear end (6), and at least one blade 34. (9) according to any one of claims 1 to 33, characterized in that (9) has a serrated surface structure and the sharp side of the saw blade faces the rear end (6) of the locking element (3.j) The fixing device according to claim 1. 表面構造が片面に設けられていることを特徴とする、請求項34記載の固定装置。  35. Fixing device according to claim 34, characterized in that the surface structure is provided on one side. 表面構造が両面に設けられていることを特徴とする、請求項34記載の固定装置。  35. Fixing device according to claim 34, characterized in that the surface structure is provided on both sides. 係止要素(3.j)が後端(6)に隣接して長さ(L)にわたって、少なくとも1枚の刃(9)を備えた係止部分(27)を含み、少なくとも1枚の刃(9)が鱗状表面構造を有し、鱗の急峻な側が係止要素(3.j)の後端(6)の方を向いていることを特徴とする、請求項1〜33のいずれか1項記載の固定装置。  The locking element (3.j) includes a locking portion (27) with at least one blade (9) over a length (L) adjacent to the rear end (6), and at least one blade 34. (9) according to any one of claims 1 to 33, characterized in that (9) has a scaly surface structure and the steep side of the scale faces the rear end (6) of the locking element (3.j). The fixing device according to claim 1. 表面構造が片面に設けられていることを特徴とする、請求項37記載の固定装置。  38. Fixing device according to claim 37, characterized in that the surface structure is provided on one side. 表面構造が両面に設けられていることを特徴とする、請求項37記載の固定装置。  38. Fixing device according to claim 37, characterized in that the surface structure is provided on both sides. 係止部分(27)が二つの、1平面上にある刃(9)を含み、この刃が長手軸線(4)と同軸で中空体(28)によって分離されており、刃(9)が横断面で見て0.8mm〜2mmの厚さ(D)と2.5mm〜4.5mmの幅(B)とを有し、中空円筒(28)が3mm〜7mmの直径(d)を有することを特徴とする、請求項15〜30のいずれか1項記載の固定装置。  The locking part (27) comprises two blades (9) on one plane, the blades being coaxial with the longitudinal axis (4) and separated by a hollow body (28), the blade (9) being transverse It has a thickness (D) of 0.8 mm to 2 mm and a width (B) of 2.5 mm to 4.5 mm when viewed from the surface, and the hollow cylinder (28) has a diameter (d) of 3 mm to 7 mm. The fixing device according to any one of claims 15 to 30, wherein 厚さ(D)に対する幅(B)の比が1〜14であることを特徴とする、請求項15記載の固定装置。  16. Fixing device according to claim 15, characterized in that the ratio of width (B) to thickness (D) is 1-14. 厚さ(D)に対する幅(B)の比が3〜6であることを特徴とする、請求項41記載の固定装置。  42. Fixing device according to claim 41, characterized in that the ratio of width (B) to thickness (D) is 3-6. 少なくとも1枚の刃(9)が螺旋状に構成されていることを特徴とする、請求項15〜42のいずれか1項記載の固定装置。  43. Fixing device according to any one of claims 15 to 42, characterized in that at least one blade (9) is helically configured. 少なくとも1枚の刃(9)が60mm〜300mmのピッチSを有することを特徴とする、請求項43記載の固定装置。  44. Fixing device according to claim 43, characterized in that at least one blade (9) has a pitch S of 60 mm to 300 mm. 少なくとも1枚の刃(9)が100mm〜240mmのピッチSを有することを特徴とする、請求項44記載の固定装置。  45. Fixing device according to claim 44, characterized in that at least one blade (9) has a pitch S of 100 mm to 240 mm. 刃(9)の長さ(L)にわたる捩れ角αが0°〜360°であることを特徴とする、請求項43〜45のいずれか1項記載の固定装置。  46. Fixing device according to any one of claims 43 to 45, characterized in that the twist angle [alpha] over the length (L) of the blade (9) is 0 [deg.] To 360 [deg.]. 刃(9)の長さ(L)にわたる捩れ角αが0°〜180°であることを特徴とする、請求項43〜45のいずれか1項記載の固定装置。  46. Fixing device according to any one of claims 43 to 45, characterized in that the twist angle [alpha] over the length (L) of the blade (9) is 0 [deg.] To 180 [deg.]. 刃(9)の長さ(L)にわたる捩れ角αが0°〜45°であることを特徴とする、請求項43〜45のいずれか1項記載の固定装置。  46. Fixing device according to any one of claims 43 to 45, characterized in that the twist angle [alpha] over the length (L) of the blade (9) is 0 [deg.] To 45 [deg.]. 刃(9)の長さ(L)にわたる捩れ角αが45°〜90°であることを特徴とする、請求項43〜45のいずれか1項記載の固定装置。  46. Fixing device according to any one of claims 43 to 45, characterized in that the twist angle [alpha] over the length (L) of the blade (9) is 45 [deg.] To 90 [deg.]. 少なくとも1枚の刃(9)が螺旋状に捩られており、捩れが時計回りに延びていることを特徴とする、請求項15〜49のいずれか1項記載の固定装置。  50. Fixing device according to any one of claims 15 to 49, characterized in that at least one blade (9) is helically twisted and the twist extends clockwise. 少なくとも1枚の刃(9)が螺旋状に捩られており、捩れが反時計回りに延びていることを特徴とする、請求項15〜49のいずれか1項記載の固定装置。  50. Fixing device according to any one of claims 15 to 49, characterized in that at least one blade (9) is helically twisted and the twist extends counterclockwise.
JP2002547394A 2000-12-08 2000-12-08 Fixation device for fixing bones, especially vertebral bodies relative to each other Expired - Fee Related JP4588294B2 (en)

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US20040068258A1 (en) 2004-04-08
WO2002045606A1 (en) 2002-06-13
BR0017377A (en) 2003-09-16
EP1339335B1 (en) 2004-08-18
CA2433344C (en) 2009-05-19
AR031616A1 (en) 2003-09-24
AU2001216855A1 (en) 2002-06-18
ATE273661T1 (en) 2004-09-15
ES2223617T3 (en) 2005-03-01
HK1055663A1 (en) 2004-01-21
EP1339335A1 (en) 2003-09-03
US20060271053A1 (en) 2006-11-30

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